Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Position Summary

• Lead the authoring of clinical/regulatory documents and support the performance goals (including quality and timeline) for the clinical development and regulatory submission in Japan as planned by the R&D Development Teams. In addition, make challenging proposals from the viewpoint of writing strategies and processes depending on the situation, and lead the team.

• Establish cross-divisional cooperative partnership with other functions and lead to more efficient process development, according to the optimized and standardized processes and systems.

• Fulfill the role of Japan Documentation Lead and to support the inexperienced J-Doc Lead.

Position Responsibilities

• Build the storyboard to author regulatory dossier policies and align with global team based on the information provided by DT and make challenging proposals from the viewpoint of writing strategies according to the situation.

• As DOC lead, understand the global authoring regulatory dossier strategy and lead the finalizing of domestic regulatory dossiers of clinical part.

• Set an appropriate and the shortest timeline to complete authoring regulatory dossiers and comply with the timeline. In addition, make challenging proposals from the viewpoint of the process depending on the situation and shorten the target timeline.

• Propose to the team the optimal strategy for preparing regulatory submission documents and lead the process improvement based on the tendencies of each review division concerning the contents of PMDA review reports and inquiries.

• Complete the clinical modules with J-CDL/J-CS based on the storyboard.

• Manages and provides global submission materials to stakeholders as needed.

• Authoring and conducting a coordinating activity as CSR author.

• Take charge of the CSR authoring part in the inspection.

• Manage the operational execution by strategically using outsource vendors and ensure quality of deliverables.

• Comply with internal and external processes and guidelines.

• Review and edit other clinical/regulatory documents as required.

• Drive continuous process improvements by identifying and simplifying processes. Lead cross-functional business process improvements based on information from collected metrics.

• As a senior scientific writer, give advice to other scientific writers to help them improve their capabilities in creation of clinical/regulatory documents for Japan. Also, provide guidance and support to the inexperienced J-Doc Lead.

• Provide additional value by creating better collaborative work environment internally and externally to ensure that Japan team has a good communication with HQ counterparts as well as key stakeholders, such as clinical research and regulatory.

• Good communication with Global Scientific and Regulatory Documentation (GSRD) leadership team to facilitate collaboration with GSRD in Japan submission.

• Give advice to members in our organization from the viewpoint of medical writing even for irregular applications and types of applications /consultations that have not been experienced before.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1577867

Updated: 2024-04-26 01:25:11.837 UTC

Location: Chiyoda-ku-JPN

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.